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Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant
This study is currently recruiting participants.
Study NCT00305851   Information provided by National Cancer Institute (NCI)
First Received: March 21, 2006   Last Updated: February 21, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

March 21, 2006
February 21, 2009
April 2006
  • Symptoms-related distress (pain, anxiety, fatigue, mucositis, sedation, and mood) at pre- and post-sessions 2, 4, and 6, baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
  • Uncertainty in illness as assessed by the Mishel Uncertainty in Illness Scale at baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
  • Use of defensive coping as assessed immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
  • Use of positive coping as assessed immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00305851 on ClinicalTrials.gov Archive Site
  • Communication with family as assessed by Parent-Adolescent Communication at baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
  • Adaptability or cohesion as assessed by FACES II at baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
  • Perceived social support from friends, family, and healthcare providers at baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
  • Greater derived meaning from stem cell transplantation (STC) experience immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
  • Higher resilience immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
  • Quality of life at baseline, immediately after completion of study treatment, and 100 days post-transplant [ Designated as safety issue: No ]
Same as current
 
Music Therapy or Book Discussion in Improving Quality of Life in Young Patients Undergoing Stem Cell Transplant
Music Video and Adolescent/Young Adult Resilience During Transplant

RATIONALE: Music therapy or book discussion may improve quality of life in patients undergoing stem cell transplant. It is not yet known whether music therapy is more effective than book discussion in improving quality of life in patients undergoing stem cell transplant.

PURPOSE: This randomized phase III trial is studying how well music therapy works compared to listening and discussing books on tape in improving quality of life in young patients undergoing stem cell transplant.

OBJECTIVES:

  • Test the efficacy, in terms of resilience and quality of life, of a therapeutic music video (TMV) intervention vs listening and discussing books on tape (control group) for adolescents and young adults (AYA) undergoing autologous or allogeneic transplantation for cancer.
  • Qualitatively describe the perception of helpfulness and meaningfulness of a sub-group of both interventions for AYA and family members 100 days post-transplant.

OUTLINE: This is a randomized, controlled, limited multicenter study. Patients are randomized to 1 of 2 arms.

  • Arm I (books on tape [control group]): Patients undergo six 1-hour sessions twice a week for 3 weeks with a trained counselor in which they choose up to 3 books on CD and listen to the book and/or discuss their impressions and thoughts about the contents with the counselor. Patients are provided with a portable CD player to listen to the books during their hospitalization.
  • Arm II (therapeutic music video [TMV ] intervention): Patients undergo six 1-hour sessions twice a week for 3 weeks with a music therapist, designed specifically for the pre-transplant and acute phase of treatment. Phases of patient participation include song writing, recording the song with a digital accompaniment track, completing a video layout worksheet, taking photos or making drawings for the video, viewing clip art and pictures on a computer, and sharing the final video with family members and hospital staff. In both arms, patients complete questionnaires before and after sessions 2, 4, and 6 with the music therapist. Patients also complete computer-based questionnaires before hospitalization, after session six during hospitalization, and at 100 days post-transplantation.

PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.

Phase III
Interventional
Other, Randomized, Active Control
Cancer
  • Procedure: music therapy
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
130
 
April 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of an oncology condition requiring allogeneic or autologous transplantation
  • Receiving or planning to receive a myeloablative treatment regimen and 1 of the following:

    • Marrow transplantation
    • Peripheral stem cell transplantation
    • Cord blood stem cell transplantation
  • Patients with cancers that do not usually occur in childhood/adolescent or young adult populations (e.g., breast or prostate cancer) are not eligible

PATIENT CHARACTERISTICS:

  • Able to read and speak English

    • English does not need to be the primary language
  • Able to participate in the sessions as evaluated for alertness and engagement by the music therapist
  • No cognitive impairments that would make it difficult to participate in the intervention or complete questionnaires
  • Not married and not a parent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Concurrent therapy for pain control or relief of other symptoms allowed
Both
11 Years to 24 Years
No
 
United States
 
 
NCT00305851
 
COG-ANUR0631
Children's Oncology Group
  • National Cancer Institute (NCI)
  • National Institute of Nursing Research (NINR)
Study Chair: Joan E. Haase, PhD, RN Indiana University Melvin and Bren Simon Cancer Center
Investigator: Sheri L. Robb, PhD University of Missouri, Kansas City
National Cancer Institute (NCI)
February 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.